Remote patient management company Monitored Therapeutics has received FDA 510(k) clearance for its GoSpiro Home Spirometer. This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with a wide range of smartphones, tablets or PCs.
The GoSpiro collects diagnostic quality forced spirometry (FVC) and slow spirometry (SVC) with the same accuracy as hospital laboratory systems, and provides immediate feedback to patients on the quality of their test performance. The GoSpiro integrates with MTI’s GoHome Patient Health Monitor, which collects and transmits data from patients and delivers physician’s instructions to them, and joins a suite of remote patient monitoring peripherals already integrated to monitor diseases such as Asthma, COPD, heart disease, hypertension and diabetes.
“The GoSpiro’s 510(k) marks a critical milestone towards completing our system to manage patients with pulmonary disease in their homes,” Monitored Therapeutics’ Co-founder and CEO, William Zimlich, said in a statement. “This is one more step towards our goal of improving patients’ lives and reducing healthcare costs.”
Beyond helping patients manage their chronic conditions at home, Monitored Therapeutics’ technology is also designed to optimize the health care provider’s ability to receive reimbursement in today’s payer reimbursement structures for remote patient monitoring and non-face-to-face consultation visits.